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Table 4 Incidence of adverse events at age of 42 days, 4, 6, 8 and 12 months between the MFGM-enriched formula (MF), standard formula (SF) and breast-fed reference (BFR) groups of infants

From: Safety and tolerance assessment of milk fat globule membrane-enriched infant formulas in healthy term Chinese infants: a randomised multicenter controlled trial

Age

Adverse events

MF (n = 108)

SF (n = 104)

P value (MF vs SF)

BFR (n = 206)

Overall-P value

42-day

BFR (n = 202);

MF (n = 96);

SF (n = 83)

Total

2 (2.08) 1

3 (3.61)

0.66

6 (2.97)

0.83

Skin rashes

3 (3.13)

0 (0.00)

0.25

10 (4.95)

0.11

A Hordeolum

0 (0.00)

0 (0.00)

-

1 (0.50)

0.64

Upper respiratory infection 2

0 (0.00)

0 (0.00)

-

3 (1.49)

0.26

Lower respiratory infection 3

1 (1.04)

1 (1.20)

1.00

1 (0.50)

0.78

Constipation

1 (1.04)

2 (2.41)

0.60

0 (0.00)

0.11

Diarrhoea

0 (0.00)

0 (0.00)

-

1 (0.50)

0.64

Fever > 38 °C (episodes)

0(0.00)

0 (0.00)

-

1(0.50)

0.64

Days with fever

/

/

-

7

-

4-month

BFR (n = 189);

MF (n = 92);

SF (n = 83)

Total

8 (8.70)

3 (3.61)

0.22

7 (3.70)

0.16

Skin rashes

1 (1.09)

0 (0.00)

1.00

1 (0.53)

0.62

Pyrexia

1 (1.09)

0 (0.00)

1.00

3 (1.59)

0.51

Upper respiratory infection2

3 (3.26)

1 (1.20)

0.62

8 (4.23)

0.44

Lower respiratory infection3

0 (0.00)

1 (1.20)

0.47

0 (0.00)

0.18

Constipation

2 (2.17)

0 (0.00)

0.50

0 (0.00)

0.051

Diarrhoea

1 (1.09)

1 (1.20)

1.00

2 (1.06)

0.99

Fever > 38 °C (episodes)

1 (1.09)

0 (0.00)

1.00

0 (0.00)

0.23

Days with fever

10

/

-

/

 

6-month

BFR (n = 183);

MF (n = 91);

SF (n = 82)

Total

14 (15.38)

6 (7.32)

0.15

11 (6.01)

0.031

Skin rashes

0 (0.00)

0 (0.00)

-

1 (0.55)

0.62

Pyrexia

4 (4.40)

2 (2.44)

0.69

5 (2.73)

0.70

Upper respiratory infection2

4 (4.40)

0 (0.00)

0.12

4 (2.19)

0.15

Lower respiratory infection3

7 (7.69)

3 (3.66)

0.34

0 (0.00)

0.001

Diarrhoea

1 (1.10)

2 (2.44)

0.60

2 (1.09)

0.66

Fever > 38 °C (episodes)

2(2.20)

0 (0.00)

0.50

2 (1.09)

0.39

Days with fever

/

/

-

/

-

8-month

BFR (n = 183);

MF (n = 90);

SF (n = 81)

Total

11 (12.22)

18 (22.22)

0.10

32 (17.49)

0.22

Gastroenteritis

0 (0.00)

1 (1.23)

0.47

0 (0.00)

0.19

Skin rashes

1 (1.11)

0 (0.00)

1.00

0 (0.00)

0.23

Pyrexia

4 (4.44)

4 (4.94)

1.00

14 (7.65)

0.51

Upper respiratory infection2

5 (5.56)

7 (8.64)

0.55

28 (15.30)

0.040

Lower respiratory infection3

5 (5.56)

6 (7.41)

0.76

2 (1.09)

0.023

Diarrhea

1 (1.11)

5 (6.17)

0.10

2 (1.09)

0.026

Fever > 38 °C (episodes)

0 (0.00)

0 (0.00)

-

4 (2.19)

0.15

Days with fever

/

/

-

/

-

12-month

BFR (n = 182);

MF (n = 92);

SF (n = 83)

Total

25 (27.17)

19 (22.89)

0.60

41 (22.53)

0.68

Hand-foot-and-mouth disease

0 (0.00)

1 (1.20)

0.47

0 (0.00)

0.19

Gastroenteritis

1 (1.09)

0 (0.00)

1.00

0 (0.00)

0.24

Skin rashes

0 (0.00)

1 (1.20)

0.47

2 (1.10)

0.59

Pyrexia

16 (17.39)

13 (15.66)

0.84

24 (13.19)

0.63

Upper respiratory infection2

17 (18.48)

9 (10.84)

0.20

23 (12.64)

0.28

Lower respiratory infection3

3 (3.26)

1 (1.20)

0.62

6 (3.30)

0.60

Constipation

1 (1.09)

0 (0.00)

1.00

0 (0.00)

0.24

Diarrhoea

3 (3.26)

3 (3.61)

1.00

5 (2.75)

0.93

Fever > 38 °C (episodes)

5 (5.43)

1 (1.20)

0.21

10 (5.49)

0.26

Days with fever

/

/

 

/

 
  1. 1 Data in the brackets show percentage
  2. 2 Upper respiratory infection: an infection that affects the nasal passages and throat
  3. 3 Lower respiratory infection: These include bronchitis and pneumonia with using antibiotics
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